Data / Medical devices / Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented / United States
FDA-registered makers of Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented in the United States: 65 establishments
65 establishments in the United States are registered with the FDA to make Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented (product code KWT). 13 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.
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- Device
- Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- Product code
- KWT
- Country
- United States
Makers of Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Biomet, Inc. | Warsaw, IN, United States | Manufacturer | 9 | July 12, 2023 | 0 | 5 | 0 | api.fda.gov |
| Zimmer, Inc. | Warsaw, IN, United States | Contract manufacturer, Manufacturer, Manufacturer for export | 8 | June 5, 2019 | 0 | 10 | 0 | api.fda.gov |
| CATALYST ORTHOSCIENCE Inc | Naples, FL, United States | Manufacturer, Repackager or relabeler, Specification developer | 5 | September 11, 2019 | 0 | 0 | 0 | api.fda.gov |
| Depuy Orthopaedics, Inc. | Warsaw, IN, United States | Manufacturer, Specification developer | 3 | January 14, 1999 | 0 | 0 | 0 | api.fda.gov |
| Exactech, Inc. | Gainesville, FL, United States | Manufacturer | 3 | February 27, 2017 | 0 | 4 | 0 | api.fda.gov |
| SHOULDER INNOVATIONS, Inc | Grand Rapids, MI, United States | Repackager or relabeler, Specification developer | 3 | September 8, 2026 | 0 | 0 | 0 | api.fda.gov |
| DePuy Mitek, Inc. | Raynham, MA, United States | Specification developer | 1 | January 14, 1999 | 0 | 0 | 0 | api.fda.gov |
| E. Bac Si Imports LLC | Ellensburg, WA, United States | Complaint file establishment, Specification developer | 1 | August 26, 1996 | 0 | 0 | 0 | api.fda.gov |
| Encore Medical, L.P. | Austin, TX, United States | Manufacturer | 1 | June 29, 1999 | 0 | 0 | 0 | api.fda.gov |
| Exactech Sarasota | Sarasota, FL, United States | Manufacturer | 1 | April 9, 2015 | 0 | 0 | 0 | api.fda.gov |
| Lincotek Medical LLC | Vandalia, OH, United States | Contract manufacturer, Manufacturer | 1 | September 2, 2011 | 0 | 0 | 0 | api.fda.gov |
| TORNIER Inc. | Columbia City, IN, United States | Specification developer | 1 | October 30, 2025 | 0 | 0 | 0 | api.fda.gov |
| Tornier, Inc. | Bloomington, MN, United States | Complaint file establishment, Manufacturer | 1 | October 30, 2025 | 0 | 0 | 0 | api.fda.gov |
| Aps Materials, Inc. | Dayton, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Memphis | Bartlett, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Memphis | Lexington, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Warsaw | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Autocam Medical | Kentwood, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Advanced Machine, Inc. | Winchester, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Autocam Medical | Murfreesboro, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avalign Delivery Systems Division | Greenwood, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avalign Instruments & Implants | Fort Wayne, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Centex Machining, Inc. | Round Rock, TX, United States | Contract manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Complexus Medical | Mishawaka, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Depuy Orthopaedics, Inc. | Raynham, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Donson Machine Company | Alsip, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eptam Plastics, Ltd | Northfield, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Five Star Manufacturing, Inc. | New Bedford, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fx Shoulder Solutions Inc. | Addison, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Incipio Devices | Huntington, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Inc. (Monument) | Monument, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LH Medical Corporation | Fort Wayne, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lincotek Medical, LLC | Molalla, OR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LaVezzi Precision, Inc | Bloomingdale, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maitland Engineering | South Bend, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micropulse Inc | Columbia City, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mid South Precision | Murfreesboro, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Millstone Medical Outsourcing LLC. | Fall River, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Metal Craft Machine & Engineering, Inc. | Elk River, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Millstone Medical Outsourcing LLC | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orchid Orthopedics-Chelsea | Chelsea, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orchid Unique | Bridgeport, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orchid Orthopedic Solutions Alabama LLC | Arab, AL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical, Inc. | Pierceton, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Perryman Company | Houston, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precision Edge Surgical Products Company | Sault Sainte Marie, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical - Dayton | Dayton, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical Inc. | Castleton, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical Inc. | Smithfield, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ProMade PoC Center for Complex Orthopedic Solutions at HSS | Manhattan, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rayco Steel Process, Inc. | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Restoration Medical Polymers | Columbia City, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Revelation Medical Devices, LLC | Auburn, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RMS Co. | Minneapolis, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SCT, Inc. | Franklin Lakes, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Single Source Medical LLC | Churubusco, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Medical Manufacturing Inc | Claypool, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Medical Manufacturing Inc. | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Structure Medical, LLC. | Mooresville, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Synthes (USA) Products LLC | West Chester, PA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| TriPoint Surgical | Columbia City, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viant Medical, LLC | Fort Wayne, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zimmer Trabecular Metal Technology, Inc. | Parsippany, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| rms Surgical | Anoka, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.